CEN Guide 13:2008
(Main)Validation of environmental test methods
Validation of environmental test methods
This document provides guidance on the validation tasks in the standardisation process of environmental test methods.
It deals with the two main steps of such validation tasks, the robustness testing and the interlaboratory testing (determining the repeatability and reproducibility), both interacting with the elaboration of the draft standards as shown in the flow chart given in clause 2.1. It applies to the different inter-related phases of the environmental test methods, typically sampling and production of a laboratory sample, storage and transportation of the laboratory sample, extraction, analysis or quantification of a test portion and finally reporting. Consequently this document focuses on the ‘why’ and ‘what’ of validation tasks in direct relation to the different steps of the standardisation process. This document is focussed on the validation tasks in the standardisation process of reference methods either for the whole measurement process or for part thereof.
Given the guidance aim of this document, it does not contain detailed procedures for performing the validation tasks (such as number of laboratories, number of samples, etc.).
Validacija okoljskih preskusnih metod
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-V CEN Guide 13:2009
01-junij-2009
Validacija okoljskih preskusnih metod
Validation of environmental test methods
Ta slovenski standard je istoveten z: CEN Guide 13:2008
ICS:
19.040 Preskušanje v zvezi z Environmental testing
okoljem
SIST-V CEN Guide 13:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-V CEN Guide 13:2009
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SIST-V CEN Guide 13:2009
CEN
GUIDE
13
Validation of environmental
test methods
Version dated 2008-10-29
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SIST-V CEN Guide 13:2009
CEN Guide 13 Validation of environmental test methods
Contents
Contents .2
Foreword.3
Introduction.4
1 Scope.7
2 Validation of reference methods.8
2.1 General.8
2.2 Validation of the whole measurement process .10
2.3 Validation of the sampling steps .11
2.4 First step of validation (robustness testing).12
2.5 Second step of validation (interlaboratory testing – repeatability – reproducibility).14
2.6 Final draft standard.14
3 Validation of alternative methods.16
4 Validation of guidelines .17
5 Validation of non-experimental methods.18
Annex: Explanations of terms used in this document .19
References – Bibliography .21
2
Edition 1 / October 2008
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SIST-V CEN Guide 13:2009
CEN Guide 13 Validation of environmental test methods
validation tasks interacts with the elaboration of the
draft standards, and so there is also a general need
Foreword
to document the performed validation tasks and their
results in the standard.
This document has been produced by the CEN-
This document focuses on the validation tasks in the
SABE Environmental TCs Cooperation Team (ENV
standardisation process of reference methods, being
TCs) as a policy document on validation tasks in
either the whole measurement process or one of its
the standardisation process of environmental
constituent parts.
test methods.
The environmental TCs recognise that these
Decision of TC
validation tasks are complex. They consist of two
to start a New
Work Item
main steps, the robustness testing and the inter-
Experts
laboratory testing (determining repeatability and meetings in
CEN/TC/WG
reproducibility), both interacting with the elaboration
draft standard
of the draft standards as shown in the flow chart.
based on experts
Furthermore, they apply to the different inter-related
opinions
Robustness
phases of encountered in environmental testing,
testing by
expert
typically sampling and production of laboratory
laboratory
revised draft
sample, storage and transportation, extraction,
standard based on
results robustness
analysis and reporting. Consequently, this document
testing
focuses on the ‘why’ and ‘what’ of
...
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